Work-related InjuryNCT03385954
Effectiveness of a Distance Eduaction Course for Prevention in RSI/WRMD
A study testing Intervention in people with Work-related Injury, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Repetitive Strain Injuries (RSI) or Work-Related Ostomuscular Disorders (WRMD) are musculoskeletal disorders. Nursing is one of the categories of workers most affected, due to the inherent functions they perform in their daily activities. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Work-related Injury
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2017to 30 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Nurse staff from HCPA
- Male and Female
- Individuals that agree to participate of the distance eduacational course
- Individuals that agree to participate in the research by signing the Term of Free and Clarified Consent
Who cannot join
- Individuals that do not complete the course
- Individuals that do not agree to participate in the research by signing the Term of Free and Clarified Consent
- Individuals with chronic musculoskeletal injury diagnosed.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Pôrto Alegre, Rio Grande do Sul, 90035-903
Renata c Rocha da Silva, MD, 555133598439, renatatoufpel@gmail.com
Rosane M Nery, PhD, 555133598439, rosane.nery@gmail.com
About this study
Official title: Effectiveness of a Distance Eduaction Course for Prevention in RSI/WRMD on Life Quality of a Nursing Group
Repetitive Strain Injuries (RSI) or Work-Related Ostomuscular Disorders (WRMD) are musculoskeletal disorders. Nursing is one of the categories of workers most affected, due to the inherent functions they perform in their daily activities. The objective of this study is to evaluate the effects of a distance education program of prevention in RIS/WRMD on the quality of life of a nursing group.
Read the detailed description
Repetitive Strain Injury (RSI) or Work-Related Musculoskeletaldisorders (WRMD) are the names given to skeletal muscle disorders that mainly affect the upper limbs, the scapular region and the neck. One of the most affected categories is nursing workers who present health problems inherent to the function they perform in their daily activities. Due to this peculiarity, several studies are focused on the occupational risks of nursing workers in the hospital environment. However, It was not found in the literature studies that suggests strategies to prevent and improve the worker's quality of life. Distance education comes as a differential. It has power in interactive media and collaborative learning beyond self-learning and mass media. This research project proposes to carry out a randomized clinical trial where the intervention group will receive a Prevention Course in RSI/WRMD in the distance education modality and the control group will receive Educational Lectures on Prevention in RSI /WRMD, both groups will be composed by a nursing team from the Clinical Hospital of Porto Alegre.
- Conditions
- Work-related Injury
- Being tested
- Intervention, Control
- Keywords
- nursing, distance, education, RSI/WRMD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
The distance eduacation group course has a workload of 8 hours and will be developed over 2 weeks. It is suggested that students have a minimum of 1 hour of study per day. The course will consist of work tips, clarifications and procedures for the prevention of RIS/WRMD physical training tips to improve cardiovascular condition and, of strength and flexibility, available literature and theoretical evidence that should be answered through the knowledge acquired in the EAD course of prevention of LERDORT from the HCPA's Physiatrics and Rehabilitation Service. This Course will be available through moodle.
ControlOther
will receive a lecture of 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | distance education curse with 8 hours to be accomplished in 2 weeks, Receives: Other: Intervention |
| Control | Experimental | Wiil receive a lecture of 30 minutes Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Verified by instrument SF36 - With 36 items that measure eight domains (variables): functional capacity, physical aspects, pain, general health, vitality, social aspects, emotional aspects and mental health. The highest score for each SF-36 domain is 100 and the lowest score is 0.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start1 Mar 2017
- Primary completion30 Mar 2019 (estimated)
- Study completion30 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Work-related InjuryStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antônio C dos Santos, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385954
- Sponsor's protocol ID
- 160415
- Status last verified
- Oct 2017
- First submitted
- 21 Dec 2017
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Corlett EN, Bishop RP. A technique for assessing postural discomfort. Ergonomics. 1976 Mar;19(2):175-82. doi: 10.1080/00140137608931530. No abstract available.
PubMed 1278144Lincoln AE, Feuerstein M, Shaw WS, Miller VI. Impact of case manager training on worksite accommodations in workers' compensation claimants with upper extremity disorders. J Occup Environ Med. 2002 Mar;44(3):237-45. doi: 10.1097/00043764-200203000-00011.
PubMed 11911025
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Distance Eduaction Course for Prevention in RSI/WRMD on Life Quality of a Nursing Group
- ClinicalTrials.gov ID
- NCT03385954
- Acronym / sponsor ID
- 160415
- Conditions
- Work-related Injury
- Keywords
- nursing, distance, education, RSI/WRMD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Mar 2019 (estimated)
- Study completion
- 30 Mar 2019 (estimated)
- First posted
- 29 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Repetitive Strain Injuries (RSI) or Work-Related Ostomuscular Disorders (WRMD) are musculoskeletal disorders. Nursing is one of the categories of workers most affected, due to the inherent functions they perform in their daily activities. The objective of this study is to evaluate the effects of a distance education program of prevention in RIS/WRMD on the quality of life of a nursing group.
Detailed description
Repetitive Strain Injury (RSI) or Work-Related Musculoskeletaldisorders (WRMD) are the names given to skeletal muscle disorders that mainly affect the upper limbs, the scapular region and the neck. One of the most affected categories is nursing workers who present health problems inherent to the function they perform in their daily activities. Due to this peculiarity, several studies are focused on the occupational risks of nursing workers in the hospital environment. However, It was not found in the literature studies that suggests strategies to prevent and improve the worker's quality of life. Distance education comes as a differential. It has power in interactive media and collaborative learning beyond self-learning and mass media. This research project proposes to carry out a randomized clinical trial where the intervention group will receive a Prevention Course in RSI/WRMD in the distance education modality and the control group will receive Educational Lectures on Prevention in RSI /WRMD, both groups will be composed by a nursing team from the Clinical Hospital of Porto Alegre.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Interventiondistance education curse with 8 hours to be accomplished in 2 weeks, |
| Control | Experimental | Other: ControlWiil receive a lecture of 30 minutes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Nurse staff from HCPA
- Male and Female
- Individuals that agree to participate of the distance eduacational course
- Individuals that agree to participate in the research by signing the Term of Free and Clarified Consent
Key exclusion criteria (3 listed)
- Individuals that do not complete the course
- Individuals that do not agree to participate in the research by signing the Term of Free and Clarified Consent
- Individuals with chronic musculoskeletal injury diagnosed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionThe distance eduacation group course has a workload of 8 hours and will be developed over 2 weeks. It is suggested that students have a minimum of 1 hour of study per day. The course will consist of work tips, clarifications and procedures for the prevention of RIS/WRMD physical training tips to improve cardiovascular condition and, of strength and flexibility, available literature and theoretical evidence that should be answered through the knowledge acquired in the EAD course of prevention of LERDORT from the HCPA's Physiatrics and Rehabilitation Service. This Course will be available through moodle. | Other | Intervention |
| Controlwill receive a lecture of 30 minutes. | Other | Control |
Primary outcome
Quality of life
Time frame: 48 months
Verified by instrument SF36 - With 36 items that measure eight domains (variables): functional capacity, physical aspects, pain, general health, vitality, social aspects, emotional aspects and mental health. The highest score for each SF-36 domain is 100 and the lowest score is 0.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
- Background: PubMed 1278144Corlett EN, Bishop RP. A technique for assessing postural discomfort. Ergonomics. 1976 Mar;19(2):175-82. doi: 10.1080/00140137608931530. No abstract available.
- Background: PubMed 11911025Lincoln AE, Feuerstein M, Shaw WS, Miller VI. Impact of case manager training on worksite accommodations in workers' compensation claimants with upper extremity disorders. J Occup Environ Med. 2002 Mar;44(3):237-45. doi: 10.1097/00043764-200203000-00011.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antônio C dos Santos, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Work-related Injury, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Renata C Rocha da Silva, MD (555133598439, renatatoufpel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03385954, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2018.